Arrangement for connection of a medical devide to a water line

ABSTRACT

The arrangement for connection of a medical device, particularly a dialysis device, to a permeate line for the supply of permeate into the device is characterized by an adapter comprising a first supply line section with a terminal coupling member for connection to the water line, a pressure sensor and two successively arranged shut-off valves, and two second supply line sections that branch off from the first supply line member by means of a branching member. Both second supply line sections are connected to two different lines of the device in such a manner that disinfection fluid flows through both second supply line sections in a disinfection process of the device.

The present invention relates to an arrangement for connection of amedical device to a water line for the supply of water or prepared waterinto the device.

The present invention generally relates to a connection arrangement formedical devices that must be fed with water or prepared water for theiroperation. To be more specific, the present invention relates to aconnection arrangement for those medical devices that in an onlineoperation prepare the application solution required for treatment fromprepared water and from a concentrate by mixing the same, as is aboveall the case with dialysis devices.

The invention shall now be explained in connection with dialysisdevices.

The connection of such a device may be designed as a single connectionor, however, as a connection to a ring line to which several dialysisdevices are connectable.

The fluid components used in a dialysis operation must be clean by allmeans because any contamination in the dialysis fluid would endanger thepatient treated. Bacteria, toxins and fungal spores in the dialysisfluid can be life-threatening. In the monitored industrial manufactureof the dialysis concentrates from which the dialysis fluid is made bybeing mixed with prepared water or permeate in the dialysis device, asituation must be ruled out where such contamination passes into theproducts. If it nevertheless occurs in the dialysis fluid, as has so farunfortunately happened in practice, this is bound to occur duringpreparation of the ready-for-use dialysis fluid.

Non-disinfected line sections in or on the dialysis device are a majorcause for the contamination of dialysis fluid. This includes thepermeate supply line between the dialysis device and the singleconnection for permeate or the permeate ring line. This permeate supplyline is not included in the disinfection of the dialysis device in theformerly known connection systems, so that dangerous impuritiesgenerated by bacteria, toxins and fungal spores may form and collect.

It is the object of the present invention to provide an arrangement forconnection of a medical device to a water supply line, in which or bywhich the above-described danger is prevented.

This object is achieved according to the invention by the features ofpatent claim 1.

Advantageous developments of the invention are characterized in thesub-claims.

According to the invention an adapter is used for connection of thedevice, the adapter comprising a first supply line section with aterminal coupling member for connection to an associated coupling memberof the water line or permeate line, a downstream pressure sensor and twosuccessively arranged shut-off valves, a branching member, preferably aY-line section, being mounted on the other end of the first supply linesection for dividing the first supply line section into two secondsupply line sections. Said two second supply line sections are connectedto two different lines of the device in such a manner that in adisinfection mode of the device the disinfection fluid flows through thetwo second supply line sections while the two position-monitoredshut-off valves are closed. Said second supply line sections areexpediently formed by hoses which are mounted on the Y-member and can beconnected with fixed hose connections, preferably hose clips, to the twolines of the device.

In further details, it is suggested that one of the two second linesections should be connected to the water inlet line of the deviceleading to the feed container for the permeate, and that the othersecond supply line section should be connected to another line of thedevice through which disinfection fluid is flowing in the disinfectingprocess.

With this configuration the disinfection fluid will flow in adisinfecting process of the device and with correspondingly actuatedvalves not only through the two second supply line sections of theconnection system according to the invention, whereby the two secondsupply line sections are integrated into the disinfection circuit of thedevice, but this is also true for the water inlet line of the deviceleading to the feed container, which in a conventional device is notincluded in the disinfection circuit.

Thus, thanks to the connection adapter according to the invention thesupply line area between the two shut-off valves and the device properand, in addition, the permeate inlet line leading to the feed containercan be included in each disinfection of the device, so that this causeof risk found in the former connection system and regarding the purityof the fluid components is eliminated.

The second supply line section of the adapter, which is not connected tothe water inlet line of the device, but to a suitable different line,may be connected to an intermediate line section which is connected tothe said other line and in which a shut-off valve should be arranged. Ifdesired, the shut-off valve of the intermediate line section is able tosuppress the supply of permeate through said line, so that permeate isonly supplied through the second supply line section connected to thewater inlet line of the device. If the shut-off valve in theintermediate line section remains open during permeate supply, permeateis supplied through both second line sections, which may be expedientwhenever said other line also terminates in the feed container of thedevice. In a disinfecting process, the shut-off valve is opened in theintermediate line section, so that the disinfection fluid can flowthrough the intermediate line section, the second supply line sectionconnected thereto and through the other second supply line sectionfollowing said Y-member and through the water inlet line.

In more details it is suggested that the quick-action coupling membershould be part of a water-tight housing in which the pressure sensor andthe two shut-off valves are accommodated. A compact structure of theadapter according to the invention is thereby achieved.

The shut-off valves are preferably position-monitored solenoid valveswhich are actuated via the device. In the currentless state the solenoidvalves are preferably closed. This is the case in the operative phase“disinfection”. Before each treatment and each disinfection of thedevice the position of the two shut-off valves of the adapter will bechecked automatically.

The two solenoid valves form a redundant system which preventsdisinfection solution from flowing back into the permeate ring line (orpossibly a single connection line).

Further details and features of the invention become apparent from thefollowing description of preferred embodiments and from the drawings, ofwhich

FIG. 1 is a purely schematic illustration of an adapter according to theinvention; and

FIG. 2 shows the line system of a dialysis device with the connectionsystem according to the invention.

The adapter according to the invention contains a quick-action couplingmember 1 which can be coupled rapidly and easily to an associatedquick-action coupling member 2 of a permeate line 3. The quick-actioncoupling member 1 is mounted at the end of a first supply line section 4which contains downstream thereof a pressure sensor 20 and twosuccessively arranged 2/2-way valves 5 and 6 with which the flow throughthe first supply line section 4 can be selectively enabled or disabled.The two 2/2-way solenoid valves form a redundant protection system forthe permeate line 3.

Two second supply line sections 8, 9, which are formed by hoses, areconnected to a Y-branching member 7 mounted on the other end of thefirst supply line section 4.

The quick-action coupling 1, 2 is made from special steel. Power supplyto and control of the solenoid valves 5, 6 are carried out via thedialysis device. In the currentless state the solenoid valves 5, 6 areclosed.

FIG. 2 shows the connection of the adapter according to FIG. 1 to aconventional dialysis device. The supply line section 8 is connected viaa hose clip 10 to the permeate inlet line 11 of the device which isprovided with two successive valves 21 and 22 and terminates in the feedcontainer 12 of the device.

The other second supply line section 8 is connected via a hose clip 13to an intermediate line section 14 which in turn is in communicationwith a fluid line 15 of the device, which also terminates in the feedcontainer 12.

The intermediate line section 14 contains a shut-off valve 16. Ashut-off valve 17 is also interposed in line 15.

The solenoid valve 16 interposed in the intermediate member 14 isarranged such that the existing functions are thereby not changed in thedialysis device. In the operative phase “dialysis”, the permeate inletvia connection 10 into the feed container 12 for permeate is maintainedby closing valve 16.

In the operative phase “disinfection”, disinfection fluid flows in thedirection of arrow 18 through line 19. The disinfection fluid isalternately circulating through line 15 into the feed container 12 andthrough the intermediate member 14, the supply line sections 9 and 8 andthrough the permeate inlet line 11 into the feed container 12 byalternately switching valves 16 and 17. The closed solenoid valves 5 and6 prevent disinfection fluid from flowing back into the permeate ringline.

When the solenoid valve 16 is closed in the operative phase “dialysis”,free inflow of the permeate through the supply line section 8 isguaranteed.

When a dialysis device is used for performing an extracorporeal dialysistreatment, a distinction is made between three operative phases:

-   -   Standby    -   Dialysis    -   Disinfection

These three operative phases shall be described in more detailhereinafter in connection with the present invention.

Standby

In this operative state the two valves 5 and 6 are closed. Permeate fromthe most recent flushing process for the dialysis device is present inthe lines between the adapter and the dialysis device. Hence, there isno risk for patients who are dialyzed at other dialysis places on thesame permeate line.

Dialysis

The operative dialysis phase begins with the test T_(o) of the dialysisdevice. This test includes the functional elements of the adapter. Thevalves 5 and 6 are here checked for operability by the valve positionsbeing tested one after the other. A tightness check is here carried outat the same time. The pressure sensor 20 is also checked by carrying outa back-pressure and flow-pressure measurement. The flow pressuremeasurement is compared with the measurement of the reduced water inletpressure at A (FIG. 2) behind valve 21. In consideration of acorresponding tolerance the two pressure values must be identical. Ifthe deviation is too great, an error is indicated. If the two pressurevalues are close together, the T_(o) test will be continued. If in thismeasurement the flow pressure is below the desired input pressure of thedialysis device, a water shortage alarm will be initiated via valve 21.As a consequence, the dialysis device cannot complete the T_(o) test anddoes thus not start the operative dialysis phase proper. If the flowpressure is adequate, the T_(o) test will be continued. After the T_(o)test has been completed, valves 5 and 6 are opened. Valve 16 is closed.After valves 21 and 22 have been opened, permeate flows into the feedcontainer. This further ensures the free inflow in the operativedialysis phase.

Disinfection

After the dialysis treatment the dialysis device is disinfected as arule. With the use of the adapter the permeate line is to be included ineach disinfection. A distinction is made in the dialysis device betweenthe disinfection types thermal disinfection, chemo-thermal disinfectionand chemical disinfection. It is regarded as a risk for all of thelisted disinfection types that a backflow of disinfection solution mightoccur via the adapter into the permeate line during or afterdisinfection. This is possible when the pressure prevailing in thedialysis device is higher during opening of valves 5 and 6 than thepressure prevailing in the permeate line. After the operative phasedisinfection has been selected, permeate flows via connection 10 intothe dialysis device. Valves 21 and 22 are opened. Valve 16 is closed andvalve 17 is opened. The flow pressure is measured in the pressure sensor20 and compared with the measured pressure value behind valve 21. Ifboth values are within the tolerance range, the disinfection process iscontinued. If the pressure at pressure sensor 20 in the adapter issmaller than the required flow pressure in the dialysis device, valves 5and 6 are closed again. The dialysis device indicates a water shortagealarm. If the pressure sensor 20 records a sufficiently high pressure,valves 5 and 6 remain open and permeate can continue to flow into thedialysis device for disinfection. In this process permeate will onlyflow via connection 10 and valves 21 and 22. During disinfection thedisinfection fluid is circulating via valve 17. At defined intervalsvalve 17 is closed and valve 16 is opened. Thus disinfectant can alsoflow via coupling 13 to the adapter and back again via connection 10into the feed vessel. This process is repeated in the disinfection phaseseveral times. Thus the permeate supply line to the dialysis device andthe line section for permeate in the dialysis device are integrated intothe disinfecting process.

At the end of the disinfecting process a valve 23 (FIG. 2) opens and thedialysis device is flushed and freed from disinfectant. For this processpermeate must flow into the dialysis device. For this purpose valves 5and 6 must open in the adapter. This will only take place if thepressure sensor 20 at the permeate connection of the adapter senses apredetermined minimum pressure which must clearly be above the pressureprevailing in the dialysis device. If this is the case, valves 5 and 6are opened. Permeate will then flow by alternately opening and closingvalves 16 and 17 via connections 10 and 13 into the dialysis device.This ensures that the permeate supply lines leading to the dialysisdevice are flushed free. After the flushing operation the dialysisdevice will again be brought into the operative dialyzing state.

1. An arrangement for connection of a medical device to a water line for the supply of water or prepared water into the device, particularly a dialysis device, wherein an adapter is provided which comprises a first supply line section (4) with a terminal coupling member (1) for connection to the water line (3), a pressure sensor (20) and two successively arranged shut-off valves (5, 6), and two second supply line sections (8, 9) which branch off from the first supply line section (4) by means of a branching member (7), and wherein one of the second supply line sections (8) is connected via a connection (10) to the water inlet line (11) of the device, and the other one of the second supply line sections (9) is connected via a connection (13) to another line (15) of the device through which disinfection fluid is flowing in a disinfecting process.
 2. The arrangement according to claim 1, characterized in that the other one of the second supply line sections (9) is connected via the connection (13) to an intermediate line section (14) that is connected to the other line (15).
 3. The arrangement according to claim 2, characterized in that a shut-off valve (16) is arranged in the intermediate line section (14).
 4. The arrangement according to claim 1, characterized in that the coupling member is part of a housing accommodating the two shut-off valves (5, 6).
 5. The arrangement according to claim 1, characterized in that the shut-off valves (5, 6) are solenoid valves which are actuated via the device and are also powered by the device.
 6. The arrangement according to claim 5, characterized in that the solenoid valves (5, 6) are closed in the currentless state.
 7. The arrangement according to claim 1, characterized in that means are provided for automatically checking the position of the two valves (5, 6) before each treatment and disinfection.
 8. An adapter for an arrangement for connection of a medical device to a water line for the supply of water or prepared water into the device, particularly a dialysis device, according to claim
 1. 